AWARD-1

CompletedPhase 3Results posted

A Study in Participants With Type 2 Diabetes Mellitus

A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)

Lead sponsor

Eli Lilly and Company

Assets

Dulaglutide / Exenatide

Listed sites

Recruiting sites

—

Enrollment

978

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-45•HbA1c ≥7%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01064687

Org study ID11373

Secondary IDH9X-MC-GBDAEli Lilly and Company

Timeline

Milestones

Study first posted2010-02-08estimated

Last update posted2015-01-26estimated

Results first posted2015-01-26estimated

Study start2010-02 (month precision)

Primary completion2011-11actual (month precision)

Study completion2012-05actual (month precision)

Assets

Investigational agents

Dulaglutide Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications

1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication

2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications

•Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.

•Willing to inject subcutaneous (SC) medication up to 2 times per day

•Stable weight for 3 months prior to screening

•Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m^2)

•Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.

Exclusion criteria

•Type 1 Diabetes

•HbA1c equal to or less than 6.5 before randomization or at randomization

•Chronic insulin use

•Taking drugs to promote weight loss by prescription or over the counter

•Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled

•History of fluid retention or edema

•History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening

•Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility

•Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal

•Acute or chronic pancreatitis of any form

•Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 milliliters per minute (mL/min)

•History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer

•A serum calcitonin greater than or equal to 20 picograms per milliliter (pg/mL) at screening

•Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis

•History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years

•Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing

•Organ transplant except cornea

•Have enrolled in another clinical trial within the last 30 days

•Have previously signed an informed consent or participated in a LY2189265 (dulaglutide) study

•Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening

Endpoints (94)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

Cardiometabolic biomarkers

Cardiovascular outcomes

Heart failure

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks

Time frame:Baseline through 52 weeks

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any)

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265Any CV Event	3	—
Any Fatal Event	1	—
Any Non-fatal CV Event	3	—
0.75 mg LY2189265Any CV Event	2	—
Any Fatal Event	0	—
Any Non-fatal CV Event	2	—
ExenatideAny CV Event	2	—
Any Fatal Event	0	—
Any Non-fatal CV Event	2	—

Secondary/protocol endpoint

Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks

Time frame:Baseline through 52 weeks

Expanded / custom MACE composite

event count, event

componentsMyocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any), All-cause death

Weight & body composition

8 endpoints

Secondary/registry result

Change From Baseline to 26 Weeks for Body Weight

Time frame:Baseline, 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
1.5 mg LY2189265	-1.34	—
0.75 mg LY2189265	0.18	—
Exenatide	-1.14	—
Placebo	1.37	—

LS Mean Difference-2.7295% CI-3.58 – -1.85p<0.001Mixed Models Analysis

LS Mean Difference-0.2095% CI-0.88 – 0.49p0.571Mixed Models Analysis

LS Mean Difference-1.1995% CI-2.06 – -0.33p0.007Mixed Models Analysis

LS Mean Difference1.3395% CI0.64 – 2.01p<0.001Mixed Models Analysis

LS Mean Difference-2.5295% CI-3.39 – -1.65p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline to 52 Weeks for Body Weight

Time frame:Baseline, 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
1.5 mg LY2189265	-1.08	—
0.75 mg LY2189265	0.49	—
Exenatide	-0.76	—

LS Mean Difference-0.3295% CI-1.25 – 0.62p0.507Mixed Models Analysis

LS Mean Difference1.2595% CI0.32 – 2.19p0.009Mixed Models Analysis

Secondary/registry result

Change From Baseline to 26 Weeks on Body Mass Index (BMI)

Time frame:Baseline, 26 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms per meter squared (kg/m^2)	95% CI
1.5 mg LY2189265	-0.48	—
0.75 mg LY2189265	0.07	—
Exenatide	-0.41	—
Placebo	0.49	—

LS Means Difference-0.9795% CI-1.27 – -0.67p<0.001Mixed Models Analysis

LS Mean Difference-0.0795% CI-0.31 – 0.17p0.568Mixed Models Analysis

LS Mean Difference-0.4295% CI-0.72 – -0.12p0.006Mixed Models Analysis

LS Mean Difference0.4895% CI0.24 – 0.71p<0.001Mixed Models Analysis

LS Mean Difference-0.9095% CI-1.20 – -0.60p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline to 52 Weeks on Body Mass Index (BMI)

Time frame:Baseline, 52 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms per meter squared (kg/m^2)	95% CI
1.5 mg LY2189265	-0.37	—
0.75 mg LY2189265	0.18	—
Exenatide	-0.28	—

LS Mean Difference-0.0995% CI-0.42 – 0.23p0.580Mixed Models Analysis

LS Mean Difference0.4695% CI0.14 – 0.79p0.005Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to 26 Weeks for Body Weight

Time frame:Baseline, 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 Weeks for Body Weight

Time frame:Baseline, 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks on Body Mass Index (BMI)

Time frame:Baseline, 26 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 Weeks on Body Mass Index (BMI)

Time frame:Baseline, 52 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

20 endpoints

Primary/registry result

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated hemoglobin	95% CI
1.5 mg LY2189265	-1.51	—
0.75 mg LY2189265	-1.30	—
Exenatide	-0.99	—
Placebo	-0.46	—

LS Mean Difference-1.0595% CI-1.22 – -0.88p<0.001ANCOVA

Superiority analysis.

LS Mean Difference-0.5295% CI-0.66 – -0.39p<0.0001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.8495% CI-1.01 – -0.67p<0.001ANCOVA

Superiority analysis.

LS Mean Difference-0.5295% CI-0.66 – -0.39p<0.001ANCOVA

Superiority analysis.

LS Mean Difference-0.3195% CI-0.44 – -0.18p<0.001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.3195% CI-0.44 – -0.18p<0.001ANCOVA

Superiority analysis.

Primary/protocol endpoint

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated hemoglobin	95% CI
1.5 mg LY2189265	-1.36	—
0.75 mg LY2189265	-1.07	—
Exenatide	-0.80	—

LS Mean Difference-0.5695% CI-0.73 – -0.39p<0.001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.2795% CI-0.44 – -0.11p<0.001ANCOVA

Non-inferiority analysis.

LS Mean Difference-0.5695% CI-0.73 – -0.39p<0.001ANCOVA

Superiority analysis.

LS Mean Difference-0.2795% CI-0.44 – -0.11p<0.001ANCOVA

Superiority analysis.

Secondary/registry result

Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles

Time frame:Baseline, 26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
1.5 mg LY2189265	-46.82	—
0.75 mg LY2189265	-42.09	—
Exenatide	-37.48	—
Placebo	-18.07	—

LS Mean Difference-28.7695% CI-34.50 – -23.02p<0.001Mixed Models Analysis

LS Mean Difference-9.3495% CI-13.62 – -5.06p<0.001Mixed Models Analysis

LS Mean Difference-24.0295% CI-29.80 – -18.24p<0.001Mixed Models Analysis

LS Mean Difference-4.6195% CI-8.95 – -0.27p0.038Mixed Models Analysis

LS Mean Difference-19.4195% CI-25.18 – -13.65p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles

Time frame:Baseline, 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
1.5 mg LY2189265	-43.84	—
0.75 mg LY2189265	-40.62	—
Exenatide	-36.16	—

LS Mean Difference-7.6895% CI-12.84 – -2.52p0.004Mixed Models Analysis

LS Mean Difference-4.4795% CI-9.66 – 0.73p0.092Mixed Models Analysis

Secondary/registry result

Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks

Time frame:Baseline, 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg LY2189265HbA1c Less Than 7%	78.2	—
HbA1c Less Than or Equal to 6.5%	62.7	—
0.75 mg LY2189265HbA1c Less Than 7%	65.8	—
HbA1c Less Than or Equal to 6.5%	53.2	—
ExenatideHbA1c Less Than 7%	52.3	—
HbA1c Less Than or Equal to 6.5%	38.0	—
PlaceboHbA1c Less Than 7%	42.9	—
HbA1c Less Than or Equal to 6.5%	24.4	—

Odds Ratio (OR)13.195% CI7.4 – 23.4p<0.001Regression, Logistic

Odds Ratio (OR)6.295% CI3.9 – 10.1p<0.001Regression, Logistic

Odds Ratio (OR)4.895% CI2.8 – 8.0p<0.001Regression, Logistic

Odds Ratio (OR)2.395% CI1.5 – 3.5p<0.001Regression, Logistic

Odds Ratio (OR)2.195% CI1.3 – 3.5p0.004Regression, Logistic

Odds Ratio (OR)11.895% CI6.7 – 20.8p<0.001Regression, Logistic

Odds Ratio (OR)4.495% CI2.9 – 6.8p<0.001Regression, Logistic

Odds Ratio (OR)6.395% CI3.7 – 10.9p<0.001Regression, Logistic

Odds Ratio (OR)2.495% CI1.6 – 3.5p<0.001Regression, Logistic

Odds Ratio (OR)2.795% CI1.6 – 4.6p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks

Time frame:Baseline, 52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg LY2189265HbA1c Less Than 7.0%	70.8	—
HbA1c Less Than or Equal to 6.5%	57.2	—
0.75 mg LY2189265HbA1c Less Than 7.0%	59.1	—
HbA1c Less Than or Equal to 6.5%	48.3	—
ExenatideHbA1c Less Than 7.0%	49.2	—
HbA1c Less Than or Equal to 6.5%	34.6	—

Odds Ratio (OR)3.795% CI2.4 – 5.6p<0.001Regression, Logistic

Odds Ratio (OR)1.795% CI1.1 – 2.5p0.008Regression, Logistic

Odds Ratio (OR)3.595% CI2.3 – 5.1p<0.001Regression, Logistic

Odds Ratio (OR)2.195% CI1.4 – 3.1p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

Time frame:Baseline, 26 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity)

Posted result

Group	Value (least_squares_mean), percentage of HOMA2	95% CI
1.5 mg LY2189265HOMA2-%B	36.14	—
HOMA2-%S	-3.14	—
0.75 mg LY2189265HOMA2-%B	23.61	—
HOMA2-%S	1.16	—
ExenatideHOMA2-%B	15.02	—
HOMA2-%S	-1.59	—
PlaceboHOMA2-%B	0.93	—
HOMA2-%S	2.56	—

LS Mean Difference35.2195% CI27.26 – 43.16p<0.001Mixed Models Analysis

LS Mean Difference21.1295% CI14.97 – 27.28p<0.001Mixed Models Analysis

LS Mean Difference22.6895% CI14.63 – 30.72p<0.001Mixed Models Analysis

LS Mean Difference8.5995% CI2.31 – 14.87p0.007Mixed Models Analysis

LS Mean Difference14.0995% CI6.06 – 22.11p<0.001Mixed Models Analysis

LS Mean Difference-5.7095% CI-14.56 – 3.17p0.207Mixed Models Analysis

LS Mean Difference-1.5495% CI-8.41 – 5.32p0.659Mixed Models Analysis

LS Mean Difference-1.4095% CI-10.37 – 7.56p0.759Mixed Models Analysis

LS Mean Difference2.7595% CI-4.25 – 9.76p0.441Mixed Models Analysis

LS Mean Difference-4.1595% CI-13.10 – 4.79p0.362Mixed Models Analysis

Secondary/registry result/low confidence

Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

Time frame:Baseline, 52 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity), C-peptide AUC

Posted result

Group	Value (least_squares_mean), percentage of HOMA2	95% CI
1.5 mg LY2189265HOMA2-%B	35.21	—
HOMA2-%S	-7.48	—
0.75 mg LY2189265HOMA2-%B	25.69	—
HOMA2-%S	-5.49	—
ExenatideHOMA2-%B	13.57	—
HOMA2-%S	-3.75	—

LS Mean Difference21.6495% CI15.20 – 28.08p<0.001Mixed Models Analysis

LS Mean Difference12.1295% CI5.56 – 18.68p<0.001Mixed Models Analysis

LS Mean Difference-3.7395% CI-10.90 – 3.43p0.307Mixed Models Analysis

LS Mean Difference-1.7595% CI-9.05 – 5.55p0.638Mixed Models Analysis

Secondary/registry result

Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks

Time frame:Baseline through 26 weeks

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	4	—
0.75 mg LY2189265	14	—
Exenatide	13	—
Placebo	22	—

Secondary/registry result

Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks

Time frame:Baseline through 52 weeks

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	10	—
0.75 mg LY2189265	27	—
Exenatide	31	—

Secondary/protocol endpoint

Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles

Time frame:Baseline, 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles

Time frame:Baseline, 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks

Time frame:Baseline, 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks

Time frame:Baseline, 52 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

Time frame:Baseline, 26 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity), C-peptide AUC

Secondary/protocol endpoint

Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

Time frame:Baseline, 52 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity)

Secondary/protocol endpoint

Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks

Time frame:Baseline through 26 weeks

time to event, event

Secondary/protocol endpoint

Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks

Time frame:Baseline through 52 weeks

time to event, event

Heart failure

2 endpoints

Secondary/registry result

Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)

Time frame:Baseline, 26 weeks

NT-proBNP, change

change from baseline, improvement

Posted result

Group	Value (median), picograms per milliliter (pg/mL)	95% CI
1.5 mg LY2189265	-6.77	-30.45 – 15.22
0.75 mg LY2189265	-2.96	-22.83 – 19.45
Exenatide	-3.38	-31.29 – 18.61
Placebo	-0.85	-25.37 – 17.76

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)

Time frame:Baseline, 26 weeks

NT-proBNP, change

change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/registry result

Change in Baseline to 26 Weeks on Pulse Rate

Time frame:Baseline, 26 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
1.5 mg LY2189265	2.80	—
0.75 mg LY2189265	2.80	—
Exenatide	1.18	—
Placebo	0.61	—

Secondary/registry result

Change in Baseline to 52 Weeks on Pulse Rate

Time frame:Baseline, 52 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
1.5 mg LY2189265	1.68	—
0.75 mg LY2189265	1.56	—
Exenatide	1.15	—

Secondary/registry result

Change From Baseline to 26 Weeks on Blood Pressure

Time frame:Baseline, 26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 mg LY2189265Seated SBP (n=263, 266, 259, 127)	0.11	—
Seated DBP (n=263, 266, 259, 127)	0.76	—
0.75 mg LY2189265Seated SBP (n=263, 266, 259, 127)	-0.36	—
Seated DBP (n=263, 266, 259, 127)	0.56	—
ExenatideSeated SBP (n=263, 266, 259, 127)	0.06	—
Seated DBP (n=263, 266, 259, 127)	-0.11	—
PlaceboSeated SBP (n=263, 266, 259, 127)	3.40	—
Seated DBP (n=263, 266, 259, 127)	1.25	—

Secondary/registry result

Change From Baseline to 52 Weeks on Blood Pressure

Time frame:Baseline, 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), millimeters of mercury (mmHg)	95% CI
1.5 mg LY2189265Seated SBP (n=248, 256, 238)	0.83	—
Seated DBP (n=248, 256, 238)	0.89	—
0.75 mg LY2189265Seated SBP (n=248, 256, 238)	1.62	—
Seated DBP (n=248, 256, 238)	0.76	—
ExenatideSeated SBP (n=248, 256, 238)	0.02	—
Seated DBP (n=248, 256, 238)	0.02	—

Secondary/protocol endpoint

Change in Baseline to 26 Weeks on Pulse Rate

Time frame:Baseline, 26 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Baseline to 52 Weeks on Pulse Rate

Time frame:Baseline, 52 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks on Blood Pressure

Time frame:Baseline, 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 Weeks on Blood Pressure

Time frame:Baseline, 52 weeks

change from baseline, improvement

Patient-reported / QoL

16 endpoints

Secondary/registry result

Change From Baseline to 26 Weeks in the EuroQol 5

Time frame:Baseline, 26 weeks

EQ-5D index

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265VAS Health State Score (n=270, 267, 264, 119)	4.50	—
EQ-5D UK (n=270, 266, 264, 119)	0.01	—
0.75 mg LY2189265VAS Health State Score (n=270, 267, 264, 119)	2.41	—
EQ-5D UK (n=270, 266, 264, 119)	0.01	—
ExenatideVAS Health State Score (n=270, 267, 264, 119)	3.94	—
EQ-5D UK (n=270, 266, 264, 119)	0.00	—
PlaceboVAS Health State Score (n=270, 267, 264, 119)	0.71	—
EQ-5D UK (n=270, 266, 264, 119)	-0.00	—

Secondary/registry result

Change From Baseline to 52 Weeks in the EuroQol 5

Time frame:Baseline, 52 weeks

EQ-5D index

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265VAS Health State Score (n=270, 267, 264)	5.15	—
EQ-5D UK (n=270, 266, 264)	0.02	—
0.75 mg LY2189265VAS Health State Score (n=270, 267, 264)	3.52	—
EQ-5D UK (n=270, 266, 264)	0.01	—
ExenatideVAS Health State Score (n=270, 267, 264)	3.51	—
EQ-5D UK (n=270, 266, 264)	-0.00	—

Secondary/registry result

Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version

Time frame:Baseline, 26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265	2.40	—
0.75 mg LY2189265	2.56	—
Exenatide	0.85	—
Placebo	0.49	—

Secondary/registry result

Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions

Time frame:Baseline, 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265DTSQs Treatment Satisfaction (n=270, 268, 266)	2.05	—
DTSQc Treatment Satisfaction (n=249, 237, 226)	15.36	—
0.75 mg LY2189265DTSQs Treatment Satisfaction (n=270, 268, 266)	2.11	—
DTSQc Treatment Satisfaction (n=249, 237, 226)	15.46	—
ExenatideDTSQs Treatment Satisfaction (n=270, 268, 266)	0.69	—
DTSQc Treatment Satisfaction (n=249, 237, 226)	14.01	—

Secondary/registry result

Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living

Time frame:Baseline, 26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265	0.18	—
0.75 mg LY2189265	0.12	—
Exenatide	0.47	—
Placebo	0.03	—

Secondary/registry result

Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living

Time frame:Baseline, 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265	0.18	—
0.75 mg LY2189265	-0.18	—
Exenatide	0.35	—

Secondary/registry result

Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception

Time frame:Baseline, 26 weeks

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265	0.56	—
0.75 mg LY2189265	0.47	—
Exenatide	0.46	—
Placebo	0.45	—

Secondary/registry result

Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception

Time frame:Baseline, 52 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
1.5 mg LY2189265	0.50	—
0.75 mg LY2189265	0.47	—
Exenatide	0.64	—

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in the EuroQol 5

Time frame:Baseline, 26 weeks

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 Weeks in the EuroQol 5

Time frame:Baseline, 52 weeks

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version

Time frame:Baseline, 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions

Time frame:Baseline, 52 weeks

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living

Time frame:Baseline, 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living

Time frame:Baseline, 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception

Time frame:Baseline, 26 weeks

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception

Time frame:Baseline, 52 weeks

change from baseline, improvement

Safety / tolerability / PK

38 endpoints

Secondary/registry result

Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 26 weeks

change from baseline, descriptive

componentsqtc f interval change, pr interval change

Posted result

Group	Value (least_squares_mean), milliseconds (msec)	95% CI
1.5 mg LY2189265QTcF Interval (n=253, 260, 250, 120)	-1.11	—
PR Interval (n=252, 259, 246, 116)	2.35	—
0.75 mg LY2189265QTcF Interval (n=253, 260, 250, 120)	0.91	—
PR Interval (n=252, 259, 246, 116)	0.93	—
ExenatideQTcF Interval (n=253, 260, 250, 120)	1.21	—
PR Interval (n=252, 259, 246, 116)	1.01	—
PlaceboQTcF Interval (n=253, 260, 250, 120)	1.32	—
PR Interval (n=252, 259, 246, 116)	-1.83	—

Secondary/registry result

Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 52 weeks

change from baseline, descriptive

componentsqtc f interval, pr interval

Posted result

Group	Value (least_squares_mean), milliseconds (msec)	95% CI
1.5 mg LY2189265QTcF Interval (n=239, 243, 226)	1.28	—
PR Interval (n=237, 243, 220)	2.57	—
0.75 mg LY2189265QTcF Interval (n=239, 243, 226)	2.30	—
PR Interval (n=237, 243, 220)	0.69	—
ExenatideQTcF Interval (n=239, 243, 226)	2.52	—
PR Interval (n=237, 243, 220)	-0.82	—

Secondary/registry result

Number of Participants With Adjudicated Pancreatitis at 26 Weeks

Time frame:Baseline through 26 weeks

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	0	—
0.75 mg LY2189265	0	—
Exenatide	0	—
Placebo	0	—

Secondary/registry result

Number of Participants With Adjudicated Pancreatitis at 52 Weeks

Time frame:Baseline through 52 weeks

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	1	—
0.75 mg LY2189265	0	—
Exenatide	0	—
Placebo/1.5 mg LY2189265	0	—
Placebo/0.75 mg LY2189265	0	—

Secondary/registry result

Change From Baseline to 26 Weeks on Pancreatic Enzymes

Time frame:Baseline, 26 weeks

change from baseline, descriptive

Posted result

Group	Value (median), units per liter	95% CI
1.5 mg LY2189265Amylase, Total (n=253, 253, 254, 127)	12.50	-3.57 – 28.85
Amylase, Pancreas-derived (n=237, 247, 246, 122)	14.81	0.00 – 35.00
Lipase (n=198, 203, 222, 114)	10.34	-7.50 – 29.41
0.75 mg LY2189265Amylase, Total (n=253, 253, 254, 127)	3.28	-9.88 – 20.00
Amylase, Pancreas-derived (n=237, 247, 246, 122)	10.34	-5.88 – 26.67
Lipase (n=198, 203, 222, 114)	0.00	-15.91 – 23.08
ExenatideAmylase, Total (n=253, 253, 254, 127)	5.56	-9.52 – 18.46
Amylase, Pancreas-derived (n=237, 247, 246, 122)	5.56	-7.14 – 21.05
Lipase (n=198, 203, 222, 114)	3.94	-10.26 – 23.08
PlaceboAmylase, Total (n=253, 253, 254, 127)	-3.33	-15.79 – 11.36
Amylase, Pancreas-derived (n=237, 247, 246, 122)	-3.77	-13.33 – 13.64
Lipase (n=198, 203, 222, 114)	-9.53	-23.33 – 6.67

Secondary/registry result

Change From Baseline to 52 Weeks on Pancreatic Enzymes

Time frame:Baseline, 52 weeks

change from baseline, descriptive

Posted result

Group	Value (median), units per liter	95% CI
1.5 mg LY2189265Amylase, Total (n=255, 263, 261)	9.21	-4.95 – 23.19
Amylase, Pancreas-derived (n=236, 253, 246)	16.67	0.00 – 35.60
Lipase (n=201, 205, 221)	5.45	-7.69 – 26.92
0.75 mg LY2189265Amylase, Total (n=255, 263, 261)	2.78	-11.67 – 17.50
Amylase, Pancreas-derived (n=236, 253, 246)	7.69	-8.70 – 28.00
Lipase (n=201, 205, 221)	0.00	-18.18 – 15.63
ExenatideAmylase, Total (n=255, 263, 261)	2.38	-11.86 – 15.22
Amylase, Pancreas-derived (n=236, 253, 246)	7.85	-8.82 – 26.67
Lipase (n=201, 205, 221)	3.57	-13.95 – 22.58

Secondary/registry result

Change From Baseline to 26 Weeks on Serum Calcitonin

Time frame:Baseline, 26 weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), picograms per milliliter (pg/mL)	95% CI
1.5 mg LY2189265	0.20	—
0.75 mg LY2189265	0.22	—
Exenatide	0.05	—
Placebo	0.05	—

Secondary/registry result

Change From Baseline to 52 Weeks on Serum Calcitonin

Time frame:Baseline, 52 weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), picograms per milliliter (pg/mL)	95% CI
1.5 mg LY2189265	0.21	—
0.75 mg LY2189265	0.05	—
Exenatide	0.10	—

Secondary/registry result

Number of Self-reported Hypoglycemic Events at 26 Weeks

Time frame:Baseline through 26 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), events	95% CI
1.5 mg LY2189265Severe HE	0	—
Documented Symptomatic HE	31	—
Asymptomatic HE	26	—
Nocturnal HE	9	—
Probable Symptomatic HE	5	—
0.75 mg LY2189265Severe HE	0	—
Documented Symptomatic HE	25	—
Asymptomatic HE	95	—
Nocturnal HE	15	—
Probable Symptomatic HE	16	—
ExenatideSevere HE	1	—
Documented Symptomatic HE	146	—
Asymptomatic HE	51	—
Nocturnal HE	31	—
Probable Symptomatic HE	3	—
PlaceboSevere HE	0	—
Documented Symptomatic HE	4	—
Asymptomatic HE	5	—
Nocturnal HE	6	—
Probable Symptomatic HE	3	—

Secondary/registry result

Number of Self-reported Hypoglycemic Events at 52 Weeks

Time frame:Baseline through 52 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), events	95% CI
1.5 mg LY2189265Severe HE	0	—
Documented Symptomatic HE	53	—
Asymptomatic HE	47	—
Nocturnal HE	20	—
Probable Symptomatic HE	8	—
0.75 mg LY2189265Severe HE	0	—
Documented Symptomatic HE	39	—
Asymptomatic HE	157	—
Nocturnal HE	29	—
Probable Symptomatic HE	22	—
ExenatideSevere HE	2	—
Documented Symptomatic HE	205	—
Asymptomatic HE	98	—
Nocturnal HE	57	—
Probable Symptomatic HE	4	—

Secondary/registry result

Rate of Self-reported Hypoglycemic Events at 26 Weeks

Time frame:Baseline through 26 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per participant per year	95% CI
1.5 mg LY2189265Severe HE	0.00	—
Documented symptomatic HE	0.22	—
Asymptomatic HE	0.19	—
Nocturnal HE	0.06	—
Probable symptomatic HE	0.04	—
0.75 mg LY2189265Severe HE	0.00	—
Documented symptomatic HE	0.18	—
Asymptomatic HE	0.69	—
Nocturnal HE	0.19	—
Probable symptomatic HE	0.24	—
ExenatideSevere HE	0.01	—
Documented symptomatic HE	1.07	—
Asymptomatic HE	0.38	—
Nocturnal HE	0.23	—
Probable symptomatic HE	0.02	—
PlaceboSevere HE	0.00	—
Documented symptomatic HE	0.06	—
Asymptomatic HE	0.27	—
Nocturnal HE	0.27	—
Probable symptomatic HE	0.04	—

Secondary/registry result

Rate of Self-reported Hypoglycemic Events at 52 Weeks

Time frame:Baseline through 52 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per participant per year	95% CI
1.5 mg LY2189265Severe HE	0.00	—
Documented symptomatic HE	0.19	—
Asymptomatic HE	0.17	—
Nocturnal HE	0.07	—
Probable symptomatic HE	0.03	—
0.75 mg LY2189265Severe HE	0.00	—
Documented symptomatic HE	0.14	—
Asymptomatic HE	0.56	—
Nocturnal HE	0.19	—
Probable symptomatic HE	0.21	—
ExenatideSevere HE	0.01	—
Documented symptomatic HE	0.76	—
Asymptomatic HE	0.37	—
Nocturnal HE	0.21	—
Probable symptomatic HE	0.02	—

Secondary/registry result

Number of Participants With LY2189265 Antibodies at 26 Weeks

Time frame:Baseline through 26 weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
0.75 mg LY2189265 or 1.5 mg LY2189265	6	—
Exenatide	12	—
Placebo	2	—

Secondary/registry result

Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug

Time frame:26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
0.75 mg LY2189265 or 1.5 mg LY218926552 weeks	3	—
4 weeks after last study dose	1	—
Exenatide52 weeks	2	—
4 weeks after last study dose	0	—
Placebo/0.75 mg LY2189265 or 1.5 mg LY218926552 weeks	2	—
4 weeks after last study dose	1	—

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events at 26 Weeks

Time frame:Baseline through 26 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	215	—
0.75 mg LY2189265	199	—
Exenatide	198	—
Placebo	104	—

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events at 52 Weeks

Time frame:Baseline through 52 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	226	—
0.75 mg LY2189265	220	—
Exenatide	221	—
Placebo/1.5 mg LY2189265	47	—
Placebo/0.75 mg LY2189265	41	—

Secondary/registry result

Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values

Time frame:Baseline, 26 weeks

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean)	95% CI
1.5 mg LY2189265	NA	—
0.75 mg LY2189265	NA	—
Exenatide	NA	—
Placebo	NA	—

Secondary/registry result

Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values

Time frame:Baseline, 52 weeks

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean)	95% CI
1.5 mg LY2189265	NA	—
0.75 mg LY2189265	NA	—
Exenatide	NA	—

Secondary/registry result

Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265

Time frame:4 weeks, 13 weeks, 26 weeks, and 52 weeks

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanogram hours per milliliter (ng*hr/mL)	95% CI
1.5 mg LY2189265	12383	—
0.75 mg LY2189265	6627	—

Secondary/protocol endpoint

Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 26 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Number of Participants With Adjudicated Pancreatitis at 26 Weeks

Time frame:Baseline through 26 weeks

Pancreatitis

event count, event

Secondary/protocol endpoint

Number of Participants With Adjudicated Pancreatitis at 52 Weeks

Time frame:Baseline through 52 weeks

Pancreatitis

event count, event

Secondary/protocol endpoint

Change From Baseline to 26 Weeks on Pancreatic Enzymes

Time frame:Baseline, 26 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline to 52 Weeks on Pancreatic Enzymes

Time frame:Baseline, 52 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline to 26 Weeks on Serum Calcitonin

Time frame:Baseline, 26 weeks

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline to 52 Weeks on Serum Calcitonin

Time frame:Baseline, 52 weeks

Thyroid event

change from baseline, event

Secondary/protocol endpoint

Number of Self-reported Hypoglycemic Events at 26 Weeks

Time frame:Baseline through 26 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Self-reported Hypoglycemic Events at 52 Weeks

Time frame:Baseline through 52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Rate of Self-reported Hypoglycemic Events at 26 Weeks

Time frame:Baseline through 26 weeks

event count, event

Secondary/protocol endpoint

Rate of Self-reported Hypoglycemic Events at 52 Weeks

Time frame:Baseline through 52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With LY2189265 Antibodies at 26 Weeks

Time frame:Baseline through 26 weeks

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug

Time frame:26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events at 26 Weeks

Time frame:Baseline through 26 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events at 52 Weeks

Time frame:Baseline through 52 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values

Time frame:Baseline, 26 weeks

descriptive

Secondary/protocol endpoint

Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values

Time frame:Baseline, 52 weeks

descriptive

Secondary/protocol endpoint

Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265

Time frame:4 weeks, 13 weeks, 26 weeks, and 52 weeks

AUC₀–∞

concentration, descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes.
Cardiovascular diabetology2023 Mar 9PMID36894938doi:10.1186/s12933-023-01775-xvia clinicaltrials gov reference derived + pubmed nct search
Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years.
Diabetes, obesity & metabolism2016 Aug (month)PMID27161178doi:10.1111/dom.12687via clinicaltrials gov reference derived + pubmed nct search
Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme.
Diabetes, obesity & metabolism2016 Apr (month)PMID26691396doi:10.1111/dom.12624via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.